510(k) K060318

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER by Horiba Abx — Product Code CIT

K060318 is an FDA 510(k) premarket notification submitted by Horiba Abx for the device "HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on August 8, 2006. The device falls under product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Horiba Abx has at least 10 other 510(k) clearances on record.